Once años de evaluaciones económicas de productos sanitarios en la Red de Agencias de Evaluación. Calidad metodológica e impacto del coste-utilidad / Eleven years of economic evaluations of medical devices by the Spanish Network of Assessment Agencies. Methodological quality and cost-utility impact

OBJETIVO: Analizar la calidad y el impacto de los análisis de coste-utilidad de productos sanitarios realizados por la Red de Agencias de Evaluación (RedETS). MÉTODO: Los análisis de coste-utilidad de productos sanitarios se identificaron buscando entre los informes de evaluación de la base de datos de la web de RedETS (2006-2016). La calidad se evaluó con un listado de verificación de calidad de RedETS, y su impacto, comparando resultados de coste-utilidad y la inclusión en la cartera común de servicios del Sistema Nacional de Salud. Se analizó la inclusión en la cartera común si la ratio de coste-efectividad incremental superaba o no los 25.000 € por año de vida ajustado por calidad. RESULTADOS: Se encontraron 25 análisis de coste-utilidad de productos sanitarios (12 de coste-utilidad, 10 de coste-efectividad y 3 de ambos). De ellos, 15 estudios con 19 ratios de coste-utilidad seleccionados cumplían al menos 18 de 25 criterios de verificación. Asimismo, 12 de los 15 estudios cumplían 18 de los 25 criterios. Sobre el impacto, en 6 de los 19 resultados se incluyó el producto en cartera aunque la ratio superó los 25.000 € por año de vida ajustado por calidad. En tres casos se está en proceso de reevaluación; en otro, de replanteamiento una vez realizados los informes de eficacia-seguridad de nuevos dispositivos; y en dos casos se señala en la cartera que debe seguirse un protocolo. CONCLUSIONES: La mayoría de los análisis de coste-utilidad de productos sanitarios analizados cumplieron casi todos los ítems del listado de verificación y, por tanto, fueron exhaustivos. Estos análisis de coste-utilidad de productos sanitarios fueron coherentes con el marco de toma de decisiones para manejar eficientemente la cartera del Sistema Nacional de Salud

OBJECTIVE: To analyse the quality and impact of cost-utility evaluations of medical devices carried out by the Spanish Network of Assessment Agencies (RedETS). METHOD: The cost-utility evaluations of medical devices were identified by searching the evaluation reports of the RedETS website database (2006-2016). Quality and its impact were evaluated with a RedETS quality checklist, comparing cost-utility results and inclusion in the portfolio of common services of the National Health System. The portfolio inclusion status was analysed considering whether the cost-effectiveness incremental ratio was or was not less than €25,000/quality adjusted life years. RESULTS: 25 cost-utility evaluations of medical devices were found (12 cost-utility, 10 cost-effectiveness and 3 both). Fifteen selected cost-utility studies with 19 cost-utility ratios met at least 18 of 25 verification criteria. Also, 12 of the 15 studies met 19 of the 25 criteria. On the impact, in 6 out of the 19 results, the product was included in the portfolio even though the ratio exceeded €25,000/quality adjusted life years. There are three cases undergoing a re-evaluation process, another case being reconsidered once the efficacy-safety of new devices has been reported and in two cases the portfolio states that protocols are required. CONCLUSIONS: Most of the cost-utility evaluations of medical devices published by RedETS fulfil most of the items on the checklist and, therefore, were thorough. These cost-utility evaluations of medical devices are consistent with the decision-making framework to efficiently manage the National Health System portfolio

[Eleven years of economic evaluations of medical devices by the Spanish Network of Assessment Agencies. Methodological quality and cost-utility impact]. / Once años de evaluaciones económicas de productos sanitarios en la Red de Agencias de Evaluación. Calidad metodológica e impacto del coste-utilidad.

OBJECTIVE: To analyse the quality and impact of cost-utility evaluations of medical devices carried out by the Spanish Network of Assessment Agencies (RedETS). METHOD: The cost-utility evaluations of medical devices were identified by searching the evaluation reports of the RedETS website database (2006-2016). Quality and its impact were evaluated with a RedETS quality checklist, comparing cost-utility results and inclusion in the portfolio of common services of the National Health System. The portfolio inclusion status was analysed considering whether the cost-effectiveness incremental ratio was or was not less than €25,000/quality adjusted life years. RESULTS: 25 cost-utility evaluations of medical devices were found (12 cost-utility, 10 cost-effectiveness and 3 both). Fifteen selected cost-utility studies with 19 cost-utility ratios met at least 18 of 25 verification criteria. Also, 12 of the 15 studies met 19 of the 25 criteria. On the impact, in 6 out of the 19 results, the product was included in the portfolio even though the ratio exceeded €25,000/quality adjusted life years. There are three cases undergoing a re-evaluation process, another case being reconsidered once the efficacy-safety of new devices has been reported and in two cases the portfolio states that protocols are required. CONCLUSIONS: Most of the cost-utility evaluations of medical devices published by RedETS fulfil most of the items on the checklist and, therefore, were thorough. These cost-utility evaluations of medical devices are consistent with the decision-making framework to efficiently manage the National Health System portfolio.

Cost-effectiveness of cell-free DNA in maternal blood testing for prenatal detection of trisomy 21, 18 and 13: a systematic review.

The aim of this paper was to conduct a systematic review of the cost-effectiveness of the analysis of cell-free DNA in maternal blood, often called the non-invasive prenatal test (NIPT), in the prenatal screening of trisomy in chromosomes 21, 18 and 13. MEDLINE, MEDLINE in process, EMBASE, and Cochrane Library were searched in April 2017. We selected: (1) economic evaluations that estimated the costs and detected cases of trisomy 21, 18 or 13; (2) comparisons of prenatal screening with NIPT (universal or contingent strategies) and the usual screening without NIPT, (3) in pregnant women with any risk of foetal anomalies. Studies were reviewed by two researchers. Data were extracted, the methodological quality was assessed and a narrative synthesis was prepared. In total, 12 studies were included, four of them performed in Europe. Three studies evaluated NIPT as a contingent test, three studies evaluated a universal NIPT, and six studies evaluated both. The results are heterogeneous, especially for the contingent NIPT where the results range from NIPT being dominant to a dominated strategy. Universal NIPT was found to be more effective but also costlier than the usual screening, with very high incremental cost-effectiveness ratios. One advantage of screening with NIPT is lower invasive procedure-related foetal losses than with usual screening. In conclusion, the cost-effectiveness of contingent NIPT is uncertain according to several studies, while the universal NIPT is not cost-effective currently.

Telemonitoring in-home complex chronic patients from primary care in routine clinical practice: Impact on healthcare resources use.

BACKGROUND: Recent evidence indicates that home telemonitoring of chronic patients reduces the use of healthcare resources. However, further studies exploring this issue are needed in primary care. OBJECTIVES: To assess the impact of a primary care-based home telemonitoring intervention for highly unstable chronic patients on the use of healthcare resources. METHODS: A one-year follow-up before and after exploratory study, without control group, was conducted. Housebound patients with heart failure or chronic lung disease, with recurrent hospital admissions, were included. The intervention consisted of patient's self-measurements and responses to a health status questionnaire, sent daily from smartphones to a web-platform (aided by an alert system) reviewed by healthcare professionals. The primary outcome measure was the number of hospital admissions occurring 12 months before and after the intervention. Secondary outcomes were length of hospital stay and number of emergency department attendances. Primary care nurses were mainly in charge of the telemonitoring process and were assisted by the general practitioners when required. RESULTS: For the 28 patients who completed the follow-up (out of 42 included, 13 patients died and 1 discontinued the intervention), a significant reduction in hospitalizations, from 2.6 admissions/patient in the previous year (standard deviation, SD: 1.6) to 1.1 (SD: 1.5) during the one-year telemonitoring follow-up (P <0.001), and emergency department attendances, from 4.2 (SD: 2.6) to 2.1 (SD: 2.6) (P <0.001) was observed. The length of hospital stay was reduced non-significantly from 11.4 to 7.9 days. CONCLUSION: In this small exploratory study, the primary care-based telemonitoring intervention seemed to have a positive impact decreasing the number of hospital admissions and emergency department attendances.

Evaluación económica e impacto presupuestario de un procedimiento de telemedicina para el control de calidad de las espirometrías en atención primaria / Economic Assessment and Budgetary Impact of a Telemedicine Procedure and Spirometry Quality Control in the Primary Care Setting

OBJETIVO: Evaluar el impacto económico de un sistema de telemedicina en un sistema público de salud para la mejora de la calidad de las espirometrías (espirometrías forzadas [EF]) en atención primaria. MATERIAL Y MÉTODOS: Se ha evaluado el impacto económico de 9.039 EF realizadas en 51 centros de salud (2010-2013) mediante teleespirometría (TE) comparándose con el sistema habitual. RESULTADOS: El sistema de TE encarece el coste unitario de la EF (47,8 € vs. 39,7 €) (2013), pero logra una mejora en la calidad de las mismas (un 84% con buena calidad, frente a un 61% mediante el procedimiento habitual). El coste total de la TE ha sido de 431.974 € (358.306 € por sistema habitual), lo que supone un impacto económico de 73.668 € (2013). El aumento de gasto para EF de buena calidad realizadas con TE fue de 34.030 € (2010) y de 144.295 € (2013), mientras que para las pruebas con mala calidad fue de -15.525€ (2010) y de -70.627€ (2013). CONCLUSIÓN: Del análisis coste-efectividad se concluye que la TE es un 23% más costosa y un 46% más efectiva. Asimismo, el gasto sanitario es menor a medida que el número de EF realizadas mediante TE aumenta. La no realización de EF de mala calidad, no válidas, supone un ahorro que compensa el aumento del gasto por la realización mediante TE, siendo un sistema coste-efectivo

OBJECTIVE: To evaluate the economic impact of a telemedicine procedure designed to improve the quality of lung function testing (LFT) in primary care in a public healthcare system, compared with the standard method. Materials and methods: The economic impact of 9,039 LFTs performed in 51 health centers (2010-2013) using telespirometry (TS) compared to standard spirometry (SS) was studied. RESULTS: TS costs more per unit than SS (€47.80 vs. €39.70) (2013), but the quality of the TS procedure is superior (84% good quality, compared to 61% using the standard procedure). Total cost of TS was €431,974 (compared with €358,306€ for SS), generating an economic impact of €73,668 (2013). The increase in cost for good quality LFT performed using TS was €34,030 (2010) and €144,295 (2013), while the costs of poor quality tests fell by €15,525 (2010) and 70,627€ (2013). CONCLUSION: The cost-effectiveness analysis concludes that TS is 23% more expensive and 46% more effective. Healthcare costs consequently fall as the number of LFTs performed by TS rises. Avoiding poor quality, invalid LFTs generates savings that compensate for the increased costs of performing LFTs with TS, making it a cost-effective method

Economic Assessment and Budgetary Impact of a Telemedicine Procedure and Spirometry Quality Control in the Primary Care Setting.

OBJECTIVE: To evaluate the economic impact of a telemedicine procedure designed to improve the quality of lung function testing (LFT) in primary care in a public healthcare system, compared with the standard method. MATERIALS AND METHODS: The economic impact of 9,039 LFTs performed in 51 health centers (2010-2013) using telespirometry (TS) compared to standard spirometry (SS) was studied. RESULTS: TS costs more per unit than SS (€47.80 vs. €39.70) (2013), but the quality of the TS procedure is superior (84% good quality, compared to 61% using the standard procedure). Total cost of TS was €431,974 (compared with €358,306€ for SS), generating an economic impact of €73,668 (2013). The increase in cost for good quality LFT performed using TS was €34,030 (2010) and €144,295 (2013), while the costs of poor quality tests fell by €15,525 (2010) and 70,627€ (2013). CONCLUSION: The cost-effectiveness analysis concludes that TS is 23% more expensive and 46% more effective. Healthcare costs consequently fall as the number of LFTs performed by TS rises. Avoiding poor quality, invalid LFTs generates savings that compensate for the increased costs of performing LFTs with TS, making it a cost-effective method.

Telemedicine spirometry training and quality assurance program in primary care centers of a public health system.

BACKGROUND: Forced spirometry is essential for diagnosing respiratory diseases and is widely used across levels of care. However, several studies have shown that spirometry quality in primary care is not ideal, with risks of misdiagnosis. Our objective was to assess the feasibility and performance of a telemedicine-based training and quality assurance program for forced spirometry in primary care. MATERIALS AND METHODS: The two phases included (1) a 9-month pilot study involving 15 centers, in which spirometry tests were assessed by the Basque Office for Health Technology Assessment, and (2) the introduction of the program to all centers in the Public Basque Health Service. Technicians first received 4 h of training, and, subsequently, they sent all tests to the reference laboratory using the program. Quality assessment was performed in accordance with clinical guidelines (A and B, good; C-F, poor). RESULTS: In the first phase, 1,894 spirometry tests were assessed, showing an improvement in quality: acceptable quality tests increased from 57% at the beginning to 78% after 6 months and 83% after 9 months (p<0.001). In the second phase, 7,200 spirometry tests were assessed after the inclusion of 36 additional centers, maintaining the positive trend (61%, 87%, and 84% at the same time points; p<0.001). CONCLUSIONS: (1) The quality of spirometry tests improved in all centers. (2) The program provides a tool for transferring data that allows monitoring of its quality and training of technicians who perform the tests. (3) This approach is useful for improving spirometry quality in the routine practice of a public health system.

Impact of telemonitoring home care patients with heart failure or chronic lung disease from primary care on healthcare resource use (the TELBIL study randomised controlled trial).

BACKGROUND: There is growing evidence that home telemonitoring can be advantageous in societies with increasing prevalence of chronic diseases.The main objective of this study is to evaluate the effect of a primary care-based telemonitoring intervention on the number and length of hospital admissions. METHODS: A randomised controlled trial was carried out across 20 health centres in Bilbao (Basque Country, Spain) to assess the impact of home telemonitoring on in-home chronic patients compared with standard care. The study lasted for one year. Fifty-eight in-home patients, diagnosed with heart failure (HF) and/or chronic lung disease (CLD), aged 14 or above and with two or more hospital admissions in the previous year were recruited. The intervention consisted of daily patient self-measurements of respiratory-rate, heart-rate, blood pressure, oxygen saturation, weight, body temperature and the completion of a health status questionnaire using PDAs. Alerts were generated when pre-established thresholds were crossed. The control group (CG) received usual care. The primary outcome measure was the number of hospital admissions that occurred at 12 months post-randomisation. The impact of telemonitoring on the length of hospital stay, use of other healthcare resources and mortality was also explored. RESULTS: The intervention group (IG) included 28 patients and the CG 30. Patient baseline characteristics were similar in both groups. Of the 21 intervention patients followed-up for a year, 12 had some admissions (57.1%), compared to 19 of 22 controls (86.4%), being the difference statistically significant (p = 0.033, RR 0.66; 95%CI 0.44 to 0.99). The mean hospital stay was overall 9 days (SD 4.3) in the IG versus 10.7 (SD 11.2) among controls, and for cause-specific admissions 9 (SD 4.5) vs. 11.2 (SD 11.8) days, both without statistical significance (p = 0.891 and 0.927, respectively). Four patients need to be telemonitored for a year to prevent one admission (NNT). There were more telephone contacts in the IG than in the CG (22.6 -SD 16.1- vs. 8.6 -SD 7.2-, p = 0.001), but fewer home nursing visits (15.3 -SD 11.6- vs. 25.4 -SD 26.3-, respectively), though the difference was not statistically significant (p = 0.3603). CONCLUSIONS: This study shows that telemonitoring of in-home patients with HF and/or CLD notably increases the percentage of patients with no hospital admissions and indicates a trend to reduce total and cause-specific hospitalisations and hospital stay. Home telemonitoring can constitute a beneficial alternative mode of healthcare provision for medically unstable elderly patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN89041993.